NCT06150053

Brief Summary

Multi-center retrospective analysis of patients with DLBCL aged ≥80 years old treated with R-CHOP-14 compared to other regimens. Patient data including baseline characteristics, histology, dose intensity and treatment outcomes will be extracted from hospital medical electronic records. Relative dose intensity (RDI) will be calculated as the percentage of the dose intensity achieved divided by the intended dose intensity. Primary endpoints are overall (OS), progression-free (PFS) and event-free survival (EFS), defined as time from diagnosis to death, death or progression/relapse, progression/relapse or treatment discontinuation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

May 5, 2022

Last Update Submit

November 20, 2023

Conditions

DLBCLOld Age; Debility

Outcome Measures

Primary Outcomes (3)

  • Overall survival (OS) death or progression/relapse, progression/relapse or treatment discontinuation.

    time from diagnosis to death

    through study completion, an average of 2 years

  • Progression-free survival (PFS)

    time from diagnosis to death or progression/relapse

    through study completion, an average of 2 years

  • Event-free survival (EFS)

    defined as time from diagnosis to death or progression/relapse or treatment discontinuation.

    through study completion, an average of 2 years

Secondary Outcomes (1)

  • Relative Dose intensity

    within the treatment period, up to 36 weeks

Study Arms (2)

R-CHOP-14

R-mini-CHOP

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients with DLBCL

You may qualify if:

  • histologically proven, untreated diffus large B-cell lymphoma (DLBCL)
  • diagnosis between 2005 - 2019
  • age ≥80 at diagnosis

You may not qualify if:

  • \- diagnosis revision at a later timepoint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University Medical Center

Homburg, Saarland, 66424, Germany

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

May 5, 2022

First Posted

November 29, 2023

Study Start

July 1, 2018

Primary Completion

January 1, 2023

Study Completion

November 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(1)